Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00761202
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®; Drug: Sodium hyaluronate	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Optive Eyedrops	Drug: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®; Eyedrops as required, but at least 3 times per day; Other Names: Optive™ Eyedrops
Active Comparator: 2 Hylocomod Eyedrops	Drug: Sodium hyaluronate; Eyedrops as required, but at least 3 times per day; Other Names: Hylocomod

Outcome Measures

Primary Outcome Measures

1. Conjunctival Staining by Lissamine Green [week 1, month 1]

   Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)

Secondary Outcome Measures

1. Corneal Staining by Fluorescein [week 1, month 1]

   Percentage of cases of limbal staining by sodium fluorescein at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)

2. Conjunctival Hyperaemia [week 1, month 1]

   Percentage of conjunctival response reported in terms of limbal hyperaemia for the worst responses over the area at each point on a five point scale (0=clear/white conjunctiva, 1=slight redness, 2=Mild redness, 3=Moderate redness, 4=Severe redness)

3. Ocular Comfort and Ocular Symptoms on Visual Analogue Scale [week 1, month 1]

   Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)

4. Daily Eyedrop Usage [Month 1]

   Average daily eyedrop use

5. Lipid Layer Pattern Assessment [Week 1, month 1]

   Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years or over

• Contact lens wearer, spectacle wearer or non-spectacle wearer

• Mild to severe dry eye symptoms, defined as OSDI score 13 to 100

• Mild to moderate conjunctival staining in each eye and/or mild to moderate corneal staining in each eye

• Best corrected visual acuity of 6/9 in each eye

Exclusion Criteria:

• Previously used Hylocomod or Optive eyedrops

• Systemic allergy or eye allergy

• Systemic disease which might have an ocular component and/or interfere with contact lens wear

• Autoimmune disease which might have an ocular component and/or interfere with contact lens wear

• Systemic medication which might have eye side effects and or interfere with contact lens wear

• Eye infection or use of eye medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		London		United Kingdom

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT00761202
• Other Study ID Numbers: AGN/OPH/DE/002
• First Posted: Sep 29, 2008
• Last Update Posted: Nov 19, 2013
• Last Verified: Oct 1, 2013

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Carboxymethylcellulose Sodium; Hyaluronic Acid; Glycerol

Study Results

Participant Flow

Arm/Group Title	Carboxymethylcellulose and Glycerin	Sodium Hyaluronate
Arm/Group Description
Period Title: Overall Study
STARTED	22	28
COMPLETED	21	26
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Carboxymethylcellulose and Glycerin	Sodium Hyaluronate	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	21	26	47
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.8 (16.4)	39.9 (14.8)	42.0 (16.0)
Sex: Female, Male (Count of Participants)
Female	16 76.2%	20 76.9%	36 76.6%
Male	5 23.8%	6 23.1%	11 23.4%

Outcome Measures

1. Primary Outcome

Title	Conjunctival Staining by Lissamine Green
Description	Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)
Time Frame	week 1, month 1

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Carboxymethylcellulose and Glycerin	Sodium Hyaluronate
Arm/Group Description
Measure Participants	21	26
Week 1 - None	50.0 238.1%	53.8 206.9%
Week 1 - Trace	17.5 83.3%	15.4 59.2%
Week 1 - Mild	17.5 83.3%	25.0 96.2%
Week 1 - Moderate	15.0 71.4%	5.8 22.3%
Week 1 - Severe	0.0 0%	0.0 0%
Month 1 - None	78.6 374.3%	50.0 192.3%
Month 1 - Trace	11.9 56.7%	17.3 66.5%
Month 1 - Mild	9.5 45.2%	25.0 96.2%
Month 1 - Moderate	0.0 0%	7.7 29.6%
Month 1 - Severe	0.0 0%	0.0 0%

2. Secondary Outcome

Title	Corneal Staining by Fluorescein
Description	Percentage of cases of limbal staining by sodium fluorescein at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)
Time Frame	week 1, month 1

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Carboxymethylcellulose and Glycerin	Sodium Hyaluronate
Arm/Group Description
Measure Participants	21	26
Week 1 - None	45.0 214.3%	57.7 221.9%
Week 1 - Trace	25.0 119%	15.4 59.2%
Week 1 - Mild	15.0 71.4%	25.0 96.2%
Week 1 - Moderate	15.0 71.4%	1.9 7.3%
Week 1 - Severe	0.0 0%	0.0 0%
Month 1 - None	73.8 351.4%	51.9 199.6%
Month 1 - Trace	21.4 101.9%	15.4 59.2%
Month 1 - Mild	4.8 22.9%	26.9 103.5%
Month 1 - Moderate	0.0 0%	5.8 22.3%
Month 1 - Severe	0.0 0%	0.0 0%

3. Secondary Outcome

Title	Conjunctival Hyperaemia
Description	Percentage of conjunctival response reported in terms of limbal hyperaemia for the worst responses over the area at each point on a five point scale (0=clear/white conjunctiva, 1=slight redness, 2=Mild redness, 3=Moderate redness, 4=Severe redness)
Time Frame	week 1, month 1

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Carboxymethylcellulose and Glycerin	Sodium Hyaluronate
Arm/Group Description
Measure Participants	21	26
Week 1 - Clear/White	5.0 23.8%	3.8 14.6%
Week 1 - Slight	75.0 357.1%	59.6 229.2%
Week 1 - Mild	17.5 83.3%	36.5 140.4%
Week 1 - Moderate	2.5 11.9%	0.0 0%
Week 1 - Severe	0.0 0%	0.0 0%
Month 1 - Clear/White	0.0 0%	0.0 0%
Month 1 - Slight	71.4 340%	71.2 273.8%
Month 1 - Mild	28.6 136.2%	28.8 110.8%
Month 1 - Moderate	0.0 0%	0.0 0%
Month 1 - Severe	0.0 0%	0.0 0%

4. Secondary Outcome

Title	Ocular Comfort and Ocular Symptoms on Visual Analogue Scale
Description	Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)
Time Frame	week 1, month 1

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Carboxymethylcellulose and Glycerin	Sodium Hyaluronate
Arm/Group Description
Measure Participants	21	26
Ocular Comfort - Waking (Wk.1)	67.05 (24.90)	58.81 (24.73)
Ocular Comfort - Daytime (Wk.1)	63.20 (22.05)	68.21 (19.48)
Ocular Comfort - Evening (Wk.1)	57.15 (26.30)	63.38 (23.71)
Ocular Comfort - Waking (Mo.1)	65.05 (23.48)	63.56 (28.79)
Ocular Comfort - Daytime (Mo.1)	68.57 (17.25)	70.48 (23.21)
Ocular Comfort - Evening (Mo.1)	60.38 (23.29)	65.06 (23.44)

5. Secondary Outcome

Title	Daily Eyedrop Usage
Description	Average daily eyedrop use
Time Frame	Month 1

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Carboxymethylcellulose and Glycerin	Sodium Hyaluronate
Arm/Group Description
Measure Participants	21	26
Mean (Standard Deviation) [drops/day]	3.7 (1.4)	3.3 (1.0)

6. Secondary Outcome

Title	Lipid Layer Pattern Assessment
Description	Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.
Time Frame	Week 1, month 1

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Carboxymethylcellulose and Glycerin	Sodium Hyaluronate
Arm/Group Description
Measure Participants	21	26
Week 1	4.50	5.50
Month 1	3.00	5.00

Adverse Events

Arm/Group Title	Carboxymethylcellulose and Glycerin		Sodium Hyaluronate
Arm/Group Description
All Cause Mortality
	Carboxymethylcellulose and Glycerin		Sodium Hyaluronate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Carboxymethylcellulose and Glycerin		Sodium Hyaluronate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Carboxymethylcellulose and Glycerin		Sodium Hyaluronate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/21 (9.5%)		2/26 (7.7%)
Eye disorders
Upper Lid Cyst	0/21 (0%)		1/26 (3.8%)
Mild Corneal Toxicity	1/21 (4.8%)		1/26 (3.8%)
Injury, poisoning and procedural complications
Foot Injury	1/21 (4.8%)		0/26 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.